Smoking Cessation Clinical Trial
Official title:
Evaluating Digital Health Interventions To Promote Smoking Cessation
This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - daily smokers for at least 6 months - report an interest in quitting smoking. Exclusion Criteria: - reporting being currently enrolled in another quit smoking program |
Country | Name | City | State |
---|---|---|---|
United States | National online recruitment | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | American Lung Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks) | 7-day PPA at end of treatment with be confirmed via cotinine testing in saliva | 8 weeks | |
Secondary | Change in cigarettes smoked per day | Change in average number cigarettes smoked per day by self report | baseline, 4 weeks and 8 weeks | |
Secondary | Percent days smoke-free | Percentage of smoke-free days by self report | up to 8 weeks | |
Secondary | Average number of days to relapse | Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date. | 2 weeks post quit date | |
Secondary | Treatment satisfaction assessed using the User Burden Scale | User burden scale: User burden will be assessed using items on a 5 point Likert scale with scores from 0 (not at all/never) to 4 (extremely/all of the time). Means will be reported for 6 subscales (difficulty of use, physical, time and social, mental and emotional, privacy, financial) and an overall scale range 0 to 80, with higher scores indicating more user burden. | up to 8 weeks | |
Secondary | Treatment satisfaction assessed using the System Usability Scale | System usability scale: Uses 10 items ranked from 1 (strongly disagree) to 5 (strongly agree) with a total score 0-100 with higher score indicating better system usability. | up to 8 weeks | |
Secondary | Treatment satisfaction assessed using the Mobile Application Rating Scale User version | This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. | up to 8 weeks | |
Secondary | Treatment satisfaction assessed using the Acceptability of Intervention Measure | Acceptability of Intervention Measure includes three scales for Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each measure includes 4 items rated on a 5-point Likert scale from "completely disagree" to "completely agree" and average subscale responses are reported (out of 5) with higher scores indicating greater acceptability, appropriateness, or feasibility. | up to 8 weeks |
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